Cleanroom Manufacturing Technician/Assembler - 3rd Shift

Job Description

Job Description

Overview: The Cleanroom Manufacturing Technicians/Assemblers needs to be self-sufficient in assembly, testing and documentation of mechanical and electrical assemblies.

Duties & Responsibilities:

• Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures.
• Utilize small hand tools (both manual and electric), manual presses, assembly fixtures, calibrated instruments, measurement equipment, microscopes, and test fixtures.
• Utilize documentation such as Bill of Materials, product flow charts, work orders, check sheets, visual aids, production reports and assembly drawings to assemble the product and record results.
• May perform soldering, fabricating, crimping, mechanical assembly, sealing, ultra-sonic welding, bonding and gluing with adhesives, Epoxy or RTV.
• Kitting assemblies using a parts list, scanner, and inventory software as required.
• Participates in any routine start up or end of day equipment inspections or verifications.
• Inspects work throughout the assembly process and communicates any quality or operational issues to appropriate leader.
• Maintain neat, orderly and clean work area to ensure efficiency and no safety hazards. Participate in safety programs, meetings, and trainings as required.
• Participate in continuous improvement activities as part of a cross-functional team.
• Meet all quality, quantity and good manufacturing practices to satisfy customer and Regulatory Affairs requirements.
• Read and/or understand operating procedures for specific products where training has been completed.
• Work with Engineers and line leads to resolve issues and correct procedures to ensure quality and efficiency.
• Maintain Clean Room integrity by using proper attire and adherence to Clean Room environment practices and procedures as applicable.
• Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards), and special projects.
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO, QSR, and FDA regulations.

Qualifications

• Ideally seeking 2+ years hands-on experience in a manufacturing environment
• Experience with assembly, testing, and the documentation of mechanical and electrical devices
• Exceptional interpersonal, verbal, and written communication skills are required
• Willingness to undertake various tasks and adapt to unexpected situations within a dynamic company environment
• Medical device manufacturing experience is preferred
• Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes preferred
• Good hand eye coordination and manual dexterity required
• Small parts assembly and able to work under a microscope
• Utilize tweezers, torque drivers, magnifiers and microscopes